Article(id=1212693341708407024, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1212693337426018913, articleNumber=1001-2494(2024)20-1978-07, orderNo=null, doi=10.11669/cpj.2024.20.013, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1678550400000, receivedDateStr=2023-03-12, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1767058223415, onlineDateStr=2025-12-30, pubDate=1729526400000, pubDateStr=2024-10-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1767058223415, onlineIssueDateStr=2025-12-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1767058223415, creator=13701087609, updateTime=1767058223415, updator=13701087609, issue=Issue{id=1212693337426018913, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='20', pageStart='1881', pageEnd='1984', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1767058222394, creator=13701087609, updateTime=1767059439376, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1212698441885602499, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1212693337426018913, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1212698441889796804, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1212693337426018913, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1978, endPage=1984, ext={EN=ArticleExt(id=1212693342052339960, articleId=1212693341708407024, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Construction and Application of Pre-prescription Review System in A Pediatric Hospital, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To describe the incidence of inappropriate medication prescription and adverse drug reactions between 2020 and 2021 in our hospital, providing new strategies to reduce medication errors in pediatrics and providing reference for pharmacovigilance. METHODS A graded response system based on hospital information system (HIS), medication instructions and clinical guideline was constructed to provide a scientific basis for clinical intervention and management by pharmacists. The frequency, types and distribution of inappropriate medication prescription were collected by retrieving electronic medical record. By frequency analysis, composition ratio analysis and other methods, the safety, rationality, and necessity of pre-prescription review system were evaluated. RESULTS The most common types of errors identified included inappropriate refills, incorrect dose/frequency, inappropriate drug-drug interaction, off-label medication, and quantity prescribed. After the pre-prescription review system was constructed, the amounts of inappropriate medication prescription (level 5-7) in outpatient and inpatient department were decreased by 63.4% and 64.7%, respectively (P<0.05). By stratified analysis, the amounts of inappropriate medication prescription (level 5-7) in neonatal intensive care unit and cardiac intensive care unit were declined markedly (P<0.05). In addition, the incidence of adverse drug reaction was declined notably, especially the general adverse drug reactions and severe adverse drug reactions, which were decreased by 22.7% and 60.0%, respectively (P<0.05). One year after the pre-prescription review system put into service, a retrospective review of inappropriate prescriptions (level 6-7) demonstrated a 71.6%-79.2% successful intervention rate by the system. CONCLUSION The application of pre-prescription review system improved the quality and efficiency of prescription review, and it also provide opportunities for pharmacists to ensure safe and optimal prescribing.

, correspAuthors=Youhong WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Suping LI, Youhong WANG, Xiuping WU, Yinli LIU), CN=ArticleExt(id=1212693343964942663, articleId=1212693341708407024, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=儿科医院前置审方系统的构建和应用, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 分析厦门市儿童医院前置审方系统上线前后门诊药房、住院药房、静脉用药调配中心不合理处方/医嘱数量、分布和不良事件差异,探讨建立儿童用药系统知识库的必要性,为进一步加强我院儿童用药的安全性和合理性提供决策依据。方法 建立儿童用药系统知识库,基于电子病历系统、医院信息系统收集前置审方系统运行前后不合理处方/医嘱数量。通过频数分析,评价前置审方系统的合理性、有效性和必要性。结果 我院不合理处方/医嘱主要包括用法用量不适宜、给药途径不适宜、合并用药不适宜、配伍禁忌、重复用药和超说明书用药等。经前置审方系统干预后,我院门诊和住院5~7级不合理处方/医嘱数显著降低,分别减少63.4%和64.7%(P<0.05)。通过分层分析,新生儿重症监护室和心脏重症监护病区5~7不合理医嘱显著下调(P<0.05)。此外,儿童用药系统知识库的构建和前置审方系统干预可有效减少药物不良反应的发生。其中,一般药物不良反应发生率和严重药物不良反应发生率分别降低22.7%和60.0%(P<0.05)。前置审方系统上线一年,门诊和住院6~7级不合理处方/医嘱干预成功率分别为71.6%和79.2%。结论 前置审方系统的应用不仅提高了药师审方的效率和质量,而且促使临床合理用药管理体系科学化、规范化。

, correspAuthors=王幼鸿, authorNote=null, correspAuthorsNote=
* 王幼鸿,女,博士,主管药师 研究方向:临床药学 Tel:(0592)2529072
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李苏平,男,硕士,副主任药师 研究方向:医院药学

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李苏平,男,硕士,副主任药师 研究方向:医院药学

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李苏平,男,硕士,副主任药师 研究方向:医院药学

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Chin J Intern Med(中华内科杂志), 2016, 55(6):425-427., articleTitle=Individuation and precise antibiotic treatment guided by pharmacokinetics/pharmacodynamics in critically ill patients, refAbstract=null), Reference(id=1212799322115199123, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2018, volume=41, issue=6, pageStart=409, pageEnd=446, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=Infectious Diseases Committee of China Medical Education Association, journalName=Chin J Tuberc Respir Dis(中华结核和呼吸杂志), refType=null, unstructuredReference=Infectious Diseases Committee of China Medical Education Association. Expert consensus on pharmacokinetics/pharmacodynamics theory and clinical application of antibiotics[J]. Chin J Tuberc Respir Dis(中华结核和呼吸杂志), 2018, 41(6):409-446., articleTitle=Expert consensus on pharmacokinetics/pharmacodynamics theory and clinical application of antibiotics, refAbstract=null), Reference(id=1212799322232639639, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2012, volume=31, issue=5, pageStart=464, pageEnd=468, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=MYERS A L, GAEDIGK A, DAI H, journalName=Pediatr Infect Dis J, refType=null, unstructuredReference=MYERS A L, GAEDIGK A, DAI H, et al. Defining risk factors for red man syndrome in children and adults[J]. Pediatr Infect Dis J, 2012, 31(5):464-468., articleTitle=Defining risk factors for red man syndrome in children and adults, refAbstract=null), Reference(id=1212799322316525724, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2018, volume=26, issue=3, pageStart=136, pageEnd=148, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=ZHAO B, LAO D H, SHANG Y G, journalName=Chin J Clin Nutr(中华临床营养杂志), refType=null, unstructuredReference=ZHAO B, LAO D H, SHANG Y G, et al. Consensus for parenteral nutrition solutions compounding[J]. Chin J Clin Nutr(中华临床营养杂志), 2018, 26(3):136-148., articleTitle=Consensus for parenteral nutrition solutions compounding, refAbstract=null), Reference(id=1212799322400411807, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2022, volume=28, issue=4, pageStart=8, pageEnd=12, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=WEI T, LIU B, ZENG Q W, journalName=J Pediatr Pharm(儿科药学杂志), refType=null, unstructuredReference=WEI T, LIU B, ZENG Q W, et al. Investigation and analysis of clinical application of proton pump inhibitors in pediatrics in China[J]. 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(2020-12-22) [2022-12-17]. http://www.nhc.gov.cn/yzygj/s7659/202012/a7600740bed44d1db7015ca5a1be2cc0.shtml., articleTitle=Notice of the National Health Commission on the issuance of measures for the management of clinical application of anti-tumor drugs(trial), refAbstract=null), Reference(id=1212799322622709926, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2022, volume=29, issue=5, pageStart=330, pageEnd=334, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=WU J, WANG Q, journalName=Chin Pediatr Emerg Med(中国小儿急救医学), refType=null, unstructuredReference=WU J, WANG Q. Recommendations on off-label antibiotics use in PICU[J]. Chin Pediatr Emerg Med(中国小儿急救医学), 2022, 29(5):330-334., articleTitle=Recommendations on off-label antibiotics use in PICU, refAbstract=null), Reference(id=1212799322723373223, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, doi=null, pmid=null, pmcid=null, year=2015, volume=174, issue=10, pageStart=1347, pageEnd=1355, url=null, language=null, rfNumber=[27], rfOrder=26, authorNames=GLANZMANN C, FREY B, MEIER C R, journalName=Eur J Pediatr, refType=null, unstructuredReference=GLANZMANN C, FREY B, MEIER C R, et al. Analysis of medication prescribing errors in critically ill children[J]. Eur J Pediatr, 2015, 174(10): 1347-1355., articleTitle=Analysis of medication prescribing errors in critically ill children, refAbstract=null)], funds=[Fund(id=1212799318411628607, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, awardId=3502Z20227144, language=CN, fundingSource=厦门市自然科学基金项目资助(3502Z20227144), fundOrder=null, country=null), Fund(id=1212799318520680516, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, awardId=3502Z20227145, language=CN, fundingSource=厦门市自然科学基金项目资助(3502Z20227145), fundOrder=null, country=null), Fund(id=1212799318591983685, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, awardId=厦儿〔2019〕39号, language=CN, fundingSource=厦门市儿童医院“1125人才工程”培养计划项目资助(厦儿〔2019〕39号), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1212799312849982285, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, xref=null, ext=[AuthorCompanyExt(id=1212799312858370894, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, companyId=1212799312849982285, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Departmen of Pharmacy, Xiamen Children's Hospital, Xiamen 361006, China), AuthorCompanyExt(id=1212799312866759503, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, companyId=1212799312849982285, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=厦门市儿童医院药学部, 福建 厦门 361006)])], figs=[ArticleFig(id=1212799316452889579, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=uUBEhmhUN17ZX4heZ0/oig==, figureFileBig=/+1Ms+Dx37CtTQnuUQXRjg==, tableContent=null), ArticleFig(id=1212799316545164271, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图1, caption=前置审方系统在门诊/住院的分级预警和审核工作流程, figureFileSmall=uUBEhmhUN17ZX4heZ0/oig==, figureFileBig=/+1Ms+Dx37CtTQnuUQXRjg==, tableContent=null), ArticleFig(id=1212799316679382008, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=RyrD9ruFYtjen2C1LwSjHw==, figureFileBig=1Whei8Y9Xkp96W4eqNY1LQ==, tableContent=null), ArticleFig(id=1212799316805211131, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图2, caption=前置审方系统审核前后门诊/住院患者各类药物不良反应发生数统计

与干预前相比,1)P<0.05;2)P<0.01;ns-无显著差别。

, figureFileSmall=RyrD9ruFYtjen2C1LwSjHw==, figureFileBig=1Whei8Y9Xkp96W4eqNY1LQ==, tableContent=null), ArticleFig(id=1212799316956205056, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=czLcvItKJEOh1xhWw5oqGw==, figureFileBig=c8wVRK/pRQB/iO2nzzbwzA==, tableContent=null), ArticleFig(id=1212799317082034182, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图3, caption=前置审方系统上线前后不合理处方/医嘱分布情况

A-门诊不合理处方分布;B-住院不合理医嘱分布;与干预前相比,1)P<0.001,2)P<0.01;ns-无显著差别。

, figureFileSmall=czLcvItKJEOh1xhWw5oqGw==, figureFileBig=c8wVRK/pRQB/iO2nzzbwzA==, tableContent=null), ArticleFig(id=1212799317220446220, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=tBHcBquDB3fG9LrM9/Fzyw==, figureFileBig=ysy7nhnPlP7TPG3avT+1fg==, tableContent=null), ArticleFig(id=1212799317333692431, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图4, caption=前置审方系统对我院5~7级不合理处方/医嘱的干预情况

A-门诊总处方;B-门诊西药处方;C-门诊中成药处方;D-住院总医嘱;E-住院西药医嘱;F-住院中成药医嘱;与干预前相比,1)P<0.001,2)P<0.01。

, figureFileSmall=tBHcBquDB3fG9LrM9/Fzyw==, figureFileBig=ysy7nhnPlP7TPG3avT+1fg==, tableContent=null), ArticleFig(id=1212799317430161428, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=NPw9nT355ujtKSNI13LfXQ==, figureFileBig=plJzsgr3201NDsiG6A2sxQ==, tableContent=null), ArticleFig(id=1212799317576962075, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图5, caption=前置审方系统对我院5~7级静脉用药医嘱的干预情况

A-住院静脉医嘱;B-肿瘤静脉医嘱;C-肠外营养医嘱;与干预前相比,1)P<0.001;2)P<0.05;ns-无显著差别。

, figureFileSmall=NPw9nT355ujtKSNI13LfXQ==, figureFileBig=plJzsgr3201NDsiG6A2sxQ==, tableContent=null), ArticleFig(id=1212799317652459550, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=/Yrqddn1BS7FWENiuzDIgw==, figureFileBig=wq3ND/7z2y/2a06jHjOakg==, tableContent=null), ArticleFig(id=1212799317757317154, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=图6, caption=前置审方系统对我院重症单元5~7级医嘱的干预情况

A-NICU;B-CCU;C-PICU;与干预前相比,1)P<0.001;2)P<0.01;ns-无显著差别。

, figureFileSmall=/Yrqddn1BS7FWENiuzDIgw==, figureFileBig=wq3ND/7z2y/2a06jHjOakg==, tableContent=null), ArticleFig(id=1212799317916700709, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
处方等级/级 分级说明 内容 医师端/药师端提示
0 合理处方 - -
1~4 用药风险较小 1.老年、儿童用法用量尚不明确;
2.药物存在相互作用,可能引起血药浓度升高或者降低,需调整给药剂量或给药间隔,谨慎合用;
3.肝、肾功能异常患者慎用;
4.生化指标检测时间点或检测频次不适宜。
-
5 用药风险小 1.给药途径与药品说明书/资料不一致;
2.溶媒与药品说明书/资料推荐不一致,或浓度不适宜;
3.存在重复用药;
4.药物存在交叉过敏反应;
5.患者职业条件特殊,谨慎使用;
6.药物的剂量过低、给药频率或给药持续时间不适宜;
7.药物不宜合用,应避免合用;因药物相互作用引起的毒性增加。
弹框提示,医师可依情况自主判断决策。
6 用药风险较大 1.药品说明书明确禁用的给药途径;
2.药品超剂量使用,不宜、避免或不推荐使用;
3.药品间存在配伍禁忌;粉针剂需经溶解稀释后方可使用;肠外营养医嘱中钙、镁、钾离子浓度超过上限;葡萄糖浓度或渗透压超标、氨基酸浓度不适宜;
4.药品间禁止联用,避免药品间相互作用引起不良反应;
5.患者存在辅料过敏、抗生素交叉过敏反应、普通药物过敏反应;
6.疾病禁忌证;
7.患者肝肾功能异常,禁用;生化指标异常,需停药;
8.肠外营养医嘱中糖脂比、热氮比超限。
弹框提示,医师需填写用药说明,经药师审核后通过。
7 用药风险高 1.中药的配伍违反十八反十九畏;
2.抗生素、中药注射剂存在过敏反应;
3.药物的用法用量出现超极量,应禁用。
弹框提示,原则上应修改处方。特殊情况经药师核验后降级通过。
), ArticleFig(id=1212799318021558313, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=表1, caption=

前置审方系统审方规则的警示条目及级别

, figureFileSmall=null, figureFileBig=null, tableContent=
处方等级/级 分级说明 内容 医师端/药师端提示
0 合理处方 - -
1~4 用药风险较小 1.老年、儿童用法用量尚不明确;
2.药物存在相互作用,可能引起血药浓度升高或者降低,需调整给药剂量或给药间隔,谨慎合用;
3.肝、肾功能异常患者慎用;
4.生化指标检测时间点或检测频次不适宜。
-
5 用药风险小 1.给药途径与药品说明书/资料不一致;
2.溶媒与药品说明书/资料推荐不一致,或浓度不适宜;
3.存在重复用药;
4.药物存在交叉过敏反应;
5.患者职业条件特殊,谨慎使用;
6.药物的剂量过低、给药频率或给药持续时间不适宜;
7.药物不宜合用,应避免合用;因药物相互作用引起的毒性增加。
弹框提示,医师可依情况自主判断决策。
6 用药风险较大 1.药品说明书明确禁用的给药途径;
2.药品超剂量使用,不宜、避免或不推荐使用;
3.药品间存在配伍禁忌;粉针剂需经溶解稀释后方可使用;肠外营养医嘱中钙、镁、钾离子浓度超过上限;葡萄糖浓度或渗透压超标、氨基酸浓度不适宜;
4.药品间禁止联用,避免药品间相互作用引起不良反应;
5.患者存在辅料过敏、抗生素交叉过敏反应、普通药物过敏反应;
6.疾病禁忌证;
7.患者肝肾功能异常,禁用;生化指标异常,需停药;
8.肠外营养医嘱中糖脂比、热氮比超限。
弹框提示,医师需填写用药说明,经药师审核后通过。
7 用药风险高 1.中药的配伍违反十八反十九畏;
2.抗生素、中药注射剂存在过敏反应;
3.药物的用法用量出现超极量,应禁用。
弹框提示,原则上应修改处方。特殊情况经药师核验后降级通过。
), ArticleFig(id=1212799318122221615, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
时间 门诊不合理
处方总数/张
门诊成功
干预率/%
住院不合理
医嘱总数/张
住院成功
干预率/%
2021.04—2022.03 22 003 73.3 11 041 82.0
2022.04—2023.04 18 452 83.9 9 134 90.0
2023.04—2024.03 14 773 94.3 7 883 96.7
), ArticleFig(id=1212799318235467831, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1212693341708407024, language=CN, label=表2, caption=

置审方系统对厦门市儿童医院2021年4月—2024年3月6~7级不合理处方/医嘱的审查干预数据统计

, figureFileSmall=null, figureFileBig=null, tableContent=
时间 门诊不合理
处方总数/张
门诊成功
干预率/%
住院不合理
医嘱总数/张
住院成功
干预率/%
2021.04—2022.03 22 003 73.3 11 041 82.0
2022.04—2023.04 18 452 83.9 9 134 90.0
2023.04—2024.03 14 773 94.3 7 883 96.7
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儿科医院前置审方系统的构建和应用
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李苏平 , 王幼鸿 * , 吴秀萍 , 刘银丽
中国药学杂志 | 论著 2024,59(20): 1978-1984
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中国药学杂志 | 论著 2024, 59(20): 1978-1984
儿科医院前置审方系统的构建和应用
全屏
李苏平, 王幼鸿*, 吴秀萍, 刘银丽
作者信息
  • 厦门市儿童医院药学部, 福建 厦门 361006
  • 李苏平,男,硕士,副主任药师 研究方向:医院药学

通讯作者:

* 王幼鸿,女,博士,主管药师 研究方向:临床药学 Tel:(0592)2529072
Construction and Application of Pre-prescription Review System in A Pediatric Hospital
Suping LI, Youhong WANG*, Xiuping WU, Yinli LIU
Affiliations
  • Departmen of Pharmacy, Xiamen Children's Hospital, Xiamen 361006, China
出版时间: 2024-10-22 doi: 10.11669/cpj.2024.20.013
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目的 分析厦门市儿童医院前置审方系统上线前后门诊药房、住院药房、静脉用药调配中心不合理处方/医嘱数量、分布和不良事件差异,探讨建立儿童用药系统知识库的必要性,为进一步加强我院儿童用药的安全性和合理性提供决策依据。方法 建立儿童用药系统知识库,基于电子病历系统、医院信息系统收集前置审方系统运行前后不合理处方/医嘱数量。通过频数分析,评价前置审方系统的合理性、有效性和必要性。结果 我院不合理处方/医嘱主要包括用法用量不适宜、给药途径不适宜、合并用药不适宜、配伍禁忌、重复用药和超说明书用药等。经前置审方系统干预后,我院门诊和住院5~7级不合理处方/医嘱数显著降低,分别减少63.4%和64.7%(P<0.05)。通过分层分析,新生儿重症监护室和心脏重症监护病区5~7不合理医嘱显著下调(P<0.05)。此外,儿童用药系统知识库的构建和前置审方系统干预可有效减少药物不良反应的发生。其中,一般药物不良反应发生率和严重药物不良反应发生率分别降低22.7%和60.0%(P<0.05)。前置审方系统上线一年,门诊和住院6~7级不合理处方/医嘱干预成功率分别为71.6%和79.2%。结论 前置审方系统的应用不仅提高了药师审方的效率和质量,而且促使临床合理用药管理体系科学化、规范化。

儿科  /  处方  /  药物  /  审方系统  /  药师

OBJECTIVE To describe the incidence of inappropriate medication prescription and adverse drug reactions between 2020 and 2021 in our hospital, providing new strategies to reduce medication errors in pediatrics and providing reference for pharmacovigilance. METHODS A graded response system based on hospital information system (HIS), medication instructions and clinical guideline was constructed to provide a scientific basis for clinical intervention and management by pharmacists. The frequency, types and distribution of inappropriate medication prescription were collected by retrieving electronic medical record. By frequency analysis, composition ratio analysis and other methods, the safety, rationality, and necessity of pre-prescription review system were evaluated. RESULTS The most common types of errors identified included inappropriate refills, incorrect dose/frequency, inappropriate drug-drug interaction, off-label medication, and quantity prescribed. After the pre-prescription review system was constructed, the amounts of inappropriate medication prescription (level 5-7) in outpatient and inpatient department were decreased by 63.4% and 64.7%, respectively (P<0.05). By stratified analysis, the amounts of inappropriate medication prescription (level 5-7) in neonatal intensive care unit and cardiac intensive care unit were declined markedly (P<0.05). In addition, the incidence of adverse drug reaction was declined notably, especially the general adverse drug reactions and severe adverse drug reactions, which were decreased by 22.7% and 60.0%, respectively (P<0.05). One year after the pre-prescription review system put into service, a retrospective review of inappropriate prescriptions (level 6-7) demonstrated a 71.6%-79.2% successful intervention rate by the system. CONCLUSION The application of pre-prescription review system improved the quality and efficiency of prescription review, and it also provide opportunities for pharmacists to ensure safe and optimal prescribing.

pediatrics  /  prescription  /  medication  /  prescription review system  /  pharmacist
李苏平, 王幼鸿, 吴秀萍, 刘银丽. 儿科医院前置审方系统的构建和应用. 中国药学杂志, 2024 , 59 (20) : 1978 -1984 . DOI: 10.11669/cpj.2024.20.013
Suping LI, Youhong WANG, Xiuping WU, Yinli LIU. Construction and Application of Pre-prescription Review System in A Pediatric Hospital[J]. Chinese Pharmaceutical Journal, 2024 , 59 (20) : 1978 -1984 . DOI: 10.11669/cpj.2024.20.013
由于儿童用药存在不稳定性、多变性、特殊性和脆弱性特点,如何安全有效地选择药物,减少儿童用药错误是全球大部分国家都面临的难题[1]。据世界卫生组织(World Health Organization, WHO)统计,儿童用药错误发生率是成人的3倍,约为2.1%~5.7%[2]。2021年临床安全用药监测网共计收到全国275家医院19 585 例用药错误报告,其中儿童(<18岁)用药错误报告2 236例(11.58%)。相较于2020年,儿童用药错误报告增加522例。引发错误人员包括医师、药师、护士、患者及家属。其中,医师和药师是引发错误的主要人员,占比分别为72.16%和20.52%[3]。如何降低医师、药师在儿童用药中的错误率任重道远而又势在必行。
儿童用药错误类型主要包括品种(剂型、适应证、禁忌证)、用法(给药途径、给药顺序、给药速度、重复给药)、用量(规格、剂量、给药频次、给药时间、疗程)和相互作用(溶媒、配伍)等[4-7]。儿童用药错误不仅延长患者住院时间,而且增加药品不良反应发生率,引起耳聋等永久性伤害,甚至死亡。研究报告显示,每年大约有3万名儿童因用药不合理失聪,而5岁以下儿童因用药不当死亡更是高达760万人次。其中,用量相关错误居于首位[6-7]
为进一步鼓励推动儿童临床合理用药的发展,加强安全用药管理和信息预警能力,我院前期组建安全用药小组,广泛查阅国内外文献,基于药品说明书,国内外指南和临床实践经验,构建儿童用药知识库。通过优化完善前置审方系统提高药师审方准确性,减少医师不合理处方和药物相关不良事件的发生。目前,静脉输液和中药应用是儿童前置审方系统建立的重点和难点。静脉输液无吸收过程,直接进入血液循环,在短时间内达到有效治疗浓度,不仅是儿科疾病常见的给药方式,在危重症患者中更是具有举足轻重的地位。然而,相比于其他给药方式,静脉输液引起的不良反应发生率也相对较高[8]。静脉输液的实施和管理涉及患儿生理特征、病理损伤、输液浓度、输液稳定性和滴速等因素,极具异质性和复杂性。尽管中药饮片及制剂一直广泛地应用于儿科,但由于中药的复杂性和儿童的特殊性,中药研究数据在儿童应用中存在大量缺失。此外,与西药相比,中药在中医诊断库、规则梳理等方面明显不足,使得前置审方系统在儿科中成药处方干预中推广运用缓慢[9]。因此,本研究聚焦儿童静脉输液和中药应用,重点关注危重症患儿。2020年10月,我院前置审方系统正式上线,经过一年的运行,实现儿童合理用药信息化管理,现报告如下。
成立知识库构建和系统研发小组,明确工作目标、职责和要求。工作小组成员包括药师、儿科医师、信息中心技术人员和各部门管理人员。
药学人员依据药品说明书、《中国药典》2020年版、国家处方集儿童版(2013版)、中国儿童药品临床应用指南、马丁代尔药物大典(第37版)、Micromedex数据库(www.micromedexsolutions.com)、Pediatric & Neonatal Dosage Handbook(2017—2018版)、Uptodate数据库(www.uptodate.com)等制定知识库框架和明细;根据临床工作流程和内容,通过专家咨询和小组讨论征集儿科医师对系统使用、管理的具体需求和建议;信息技术人员综合考虑功能可行性、信息准确性并建立审方系统。知识库共包括用法用量、重复用药、给药途径、相互作用、生化指标、药物配伍、患者条件/特殊人群7个模块。审方系统依据表1规则对用药警示信息进行判断和分级。因超适应证用药在儿科超说明书用药中占比高,且超适应证用药不同于错误用药,其在临床使用中有一定合理性[10]。针对超适应证用药,我院经循证医学判断后,由药师集中监测、干预和管理,前置审方系统不作限制。
医师开具处方/医嘱后,先后通过审方系统进行适宜性审核和分级。1~4级处方/医嘱风险等级低,系统自动通过;5~7级处方/医嘱通过弹窗警示方式给予提示,明确处方/医嘱不适宜原因及潜在风险。其中,6级处方/医嘱需医师和药师双方签名确认后方可执行;7级处方/医嘱一般应禁止使用,特殊情况经医师、药师双方讨论沟通后进行降级,以6级处方/医嘱处理(图1)。
回顾性分析前置审方系统应用前后6个月内门诊、住院5~7级不合理处方频数及药物不良反应发生率,评价系统的有效性和必要性。系统试运行期间,系统仅对处方进行等级判断,不做弹窗和拦截处理,以此作为对照组。
统计分析使用SPSS 19.0软件(SPSS Inc., Chicago,USA)进行分析。所有数据均以平均值±标准误 ($\stackrel{-}{x}$±SEx) 表示,2组均数的比较采用配对样本t检验,非正态分布数据采用配对样本的Wilcoxon符号检验,双侧P<0.05认为具有统计学意义。
经系统干预后,一般、严重药物不良反应发生数分别减少22.7%和60.0%(图2),差异具有统计学意义(P<0.05)。前置审方系统上线半年后,本研究提取门诊、住院不合理用药(6/7级)处方及医嘱(分别为10 026张、5 343张),分析系统干预成功率。结果表明,系统成功干预门诊6~7级处方7 103张(成功干预率为70.8%)、住院6~7级医嘱4 186张(成功干预率为78.3%)。
门诊和病房是用药错误发生的主要场所[3]。我院门诊和住院不合理处方主要包括用法用量不适宜(47.3%~68.2%)、给药途径不适宜(6.7%~15.4%)、药品相互作用(7.0%~7.2%)、配伍禁忌(6.8%~18.1%)、重复给药(4.1%~5.4%)及特殊人群用药(5.0%~6.8%)(图3)。其中,门诊用法用量不适宜处方由68.2%减少至48.1%,住院特殊人群用药不适宜处方减少68.9%,干预效果显著。通过统计门诊/住院处方/医嘱数据,本研究发现系统上线前后门诊/住院总体处方/医嘱均数基本持平,但5~7级不合理处方/医嘱的频数显著降低(图4)。经系统干预后,门诊和住院5~7级不合理处方/医嘱频数显著降低,分别减少63.4%和64.7%。其中,门诊每月减少5级处方2 778张(64.5%)、6级处方220张(49.7%)、7级处方201张(68.8%)。住院5级和7级不合理处方干预后分别减少64.3%和60.0%,有效拦截的住院6级不合理医嘱是门诊的1.43倍。
经分层分析,本研究发现与系统上线前相比,系统干预后门诊/住院5~7级西药、中成药不合理处方数均显著低于干预前,差异具有统计学意义(P<0.05)。其中,前置审方系统在中成药不合理处方干预中呈现较大优势,门诊和住院中成药不合理处方/医嘱分别减少61.3%和63.4%。
前置审方系统上线前后住院每月平均静脉用药医嘱数分别为9 352和9 262份,均数基本持平,但5~7级不合理静脉用药医嘱的频数显著降低。经系统干预后,住院5、6、7级不合理静脉用药医嘱数分别减少47.2%、63.0%和45.4%(图5A),差异具有统计学意义(P<0.05)。然后,本研究对特殊静脉医嘱(肿瘤静脉用药、肠外营养医嘱)进行分层分析,发现前置审方系统干预后,5~7级肿瘤静脉用药和5、6级肠外营养不合理医嘱数均显著低于干预前,差异具有统计学意义(P<0.05)(图5B、C)。
研究发现在每月医嘱均数无统计学差异的基础上,前置审方系统上线后可有效减少新生儿重症监护室(NICU)和心脏重症监护病区(CCU)5~7级不合理医嘱数(图6)。NICU 5、6、7级不合理静脉用药医嘱数分别减少13.8%、48.3%和74.1%,CCU 5、6、7级不合理静脉用药医嘱数分别减少68.1%、75.0%和82.6%,差异均具有统计学意义(P<0.05)。然而,该系统在儿童重症医学中心(PICU)不合理处方干预上呈低效能。
PDCA循环管理方法是全面质量管理的基石,本研究围绕计划(Plan)、实施(Do)、检查(Check)和处理(Action)四个环节,持续改进审方系统,提高审方的准确率和科学性。①计划:按照处方抽样原则每月抽取并点评处方/医嘱200条,总结分析假阳性、假阴性情况及原因;②实施:针对存在问题,完善系统工程师的对接流程、加强专职审方药师的专业能力、更新评价临床循证依据等;③检查和处理:在审方工作组组长的带领下,检查每一步计划的实施效果,定期讨论分析问题并持续改进。系统上线至今,共发现11条假阳性和3条假阴性处方,其发生原因均为前置审方系统与HIS系统发生信息交互错误所致,经系统维护工程师对接口进行修改完善。本研究回顾性提取2021年4月-2024年3月的门诊/住院处方/医嘱数据,评价审方系统的改进成效。结果表明,审方系统门诊/住院6~7级处方/医嘱成功干预率逐年增加(表2)。
由于儿童用药存在特殊要求,如何选择安全、有效且适宜的药物,减少儿童用药错误是目前亟须攻克的难题。当前,我国儿童用药依然面临用药错误、药品不良反应风险,其主要原因包括:①儿童适宜品种剂型规格少;②新特药研发慢;③儿童药品临床试验开展难度大,缺乏儿童安全性数据;④超说明书或/和超指南用药;⑤临床医师缺乏药物代谢动力学和临床药理学相关专业知识。因此,为进一步加强我院儿童用药安全管理,本研究基于循证医学证据金字塔原则,首选国内外指南、药品说明书和荟萃分析,构建儿童用药知识库。本研究通过前置审方系统干预不合理处方,并重点关注中成药医嘱审核和住院静脉用药审核。研究显示,我院前置审方系统具有较好的预警准确性和功能完整性。前置审方系统的构建,使儿童用药管理信息化、全程化、规范化和标准化,有效保证儿童用药的安全性。
中成药毒副作用小,疗效稳定,辨证用药是中成药应用的主要原则。通过辨证、分析疾病的证候确定具体治法。在辨证论治的指导原则下,可以采用“同病异治”或“异病同治”的方法辨证选择适宜的中成药[11]。如最常见的感冒,中医有风寒和风热之别,荆防感冒颗粒、风寒感冒颗粒、扑感片等是专治风寒感冒的常用中成药,不宜用于风热感冒;羚羊感冒片、桑菊感冒片、银翘解毒片等则专治风热感冒。尽管同为感冒病证,但需辨证论治并选择相适应的中成药[12]。此外,中成药中的药用辅料亦是审方系统关注点之一。辅料是药物制剂中的惰性成分,辅以增加药物的稳定性和适宜性。儿科人群是一个异质群体,独特的发育特征会导致辅料在药代动力学、药效学和安全性方面与成人存在差异,并成为儿科用药的潜在风险点[13]。例如,苯甲酸可能会增加新生儿黄疸的发生风险;含有苯甲醇的药物可能会导致头痛、呕吐、腹泻[14-16];糖作为甜味剂在改善儿科口服药物适口性的同时,亦可能增加儿童心血管疾病的发生风险[17];乙醇在新生儿中枢神经系统的高渗透性和低清除率,使新生儿面临更高的毒理学风险(例如低血糖、酸中毒)[18-19]。前置审方系统的构建,可以辅助西医师正确选择适宜药品,避免重复用药,并对新生儿等特殊群体用药给予必要提示。前置审方系统上线后,门诊和住院中成药不合理处方/医嘱分别减少61.3%和63.4%,极大提高了儿童中成药使用的安全性。
儿科患者病情变化快、用药依从性较差,静脉给药是较为常用的给药途径,但使用不当可能造成严重后果。例如,万古霉素为时间依赖性抗菌药物,24 h内T>MIC至少≥40%~50%,若给药频次不足,药物浓度低于10 mg·L-1时不仅无法达到有效治疗浓度,且易诱发MRSA等细菌耐药[20-21];若滴注速度过快,儿童因肾脏处于发育阶段,特别是新生儿,药物在体内的半衰期延长,浓度增高,引起红人综合征,甚至心跳停止[22]。葡萄糖溶媒可致卡泊芬净发生降解;开具含有维生素C的肠外营养液将引起12%~14%维生素C降解为草酸或其他物质,而草酸可与钙盐形成草酸钙沉淀,影响用药安全 [23]。因此,针对静脉用药医嘱,系统重点审核药物浓度、用法用量、溶媒选择、肠外营养液配伍稳定性等问题。注射用奥美拉唑钠粉针特异性降低质子泵分泌胃酸,用于治疗消化性溃疡出血、胃食管反流病等。其在儿童中的使用经验有限,偶见肝酶升高、肝炎和黄疸等肝脏系统药物不良反应[24]。因此,对于肝功能不全者,特别是用于维持糜烂性食管炎的愈合应考虑减少剂量。我院前置审方系统在医师开具医嘱时,将自动关联并获取患者谷丙转氨酶数值。当谷丙转氨酶数值大于400 U·L-1时,系统将医嘱判定为6级医嘱,提示禁止使用;当谷丙转氨酶数值介于160~400 U·L-1之间时,则判定为5级医嘱,系统提示医师原剂量减半。
抗肿瘤药被《用药安全项目组》列为“A级高警示药品”[4],其用药合理性的重要性不言而喻,虽然系统上线后5、6级肿瘤医嘱数量显著减低,但由于肿瘤指南更新较快,系统维护不及时,针对部分超说明书用药未能及时给予医师反馈和建议。因此,以2020年《抗肿瘤药物临床应用管理办法(试行)》[25]为指导思想,在临床药师的配合下进一步完善抗肿瘤药物医嘱拦截数据库,坚持抗肿瘤药物的循证使用,提升抗肿瘤药物医嘱审核质量。
超说明书用药包括超适应证、超人群、超年龄、超剂量、超禁忌、超给药途径和给药间隔等。超说明书用药在儿科疾病中较为普遍,在PICU尤为突出。其增加药物不良反应发生风险的同时,伴随用药差错率的增加。研究表明,约42%~71%[26] PICU患儿接受了超说明书用药,用药差错率则高达14%[27]。我院危重症患儿以新生儿和一岁以下儿童为主,复杂危急的病情对用药的安全有效性有更高的要求。前置审方系统上线后,NICU、CCU 5~7级医嘱数量有不同程度的降低,但PICU高危级别医嘱无明显减少,其原因在于目前缺乏适合中国儿童特色的临床指南共识或高质量的循证医学证据,相关指南的适应性存在争议。而针对该情况,前置审方系统的信息自动获取能力和功能覆盖性稍显不足,有待进一步完善。目前,针对儿科不同人群的超说明用药推荐,我院药师需对其来源、维度、证据等级进行综合评估,随后经临床医师、药师沟通、讨论、评估后方可使用。
新生儿肠外营养医嘱是NICU、PICU医嘱审核的另一难点。新生儿肠外营养复杂性表现在药物相互作用的多维性和可变稳定性。儿童全肠外营养液涉及十余种药品、辅料和溶媒,合理性审核指标有14项左右。我院前置审方系统在肠外营养医嘱审核中设立营养物质合理配比评估(钾钠浓度、糖脂比、热氮比)、药剂学特性评估(相容性、稳定性),能够精确、高效、便捷地对医嘱进行合理用药审查。前置审方系统的构建不仅协助药师完成适宜性点评,而且为医师查阅营养组方热量、糖脂比、渗透压等参数提供依据,优化TPN医嘱的质量和审核效率。
前置审方系统通过事前干预不仅有效提高了药师审方的效率和质量,而且为临床用药管理决策提供判断依据。但其在数据更新、完善和覆盖度方面仍有不足。临床药师需基于循证药学证据对数据库内容进行提取、整合、判断、更新和备案,联合临床医师对我院儿科疾病防治领域主要用药问题进行梳理和评价分析,系统地满足儿童临床用药的安全性需求。
  • 厦门市自然科学基金项目资助(3502Z20227144)
  • 厦门市自然科学基金项目资助(3502Z20227145)
  • 厦门市儿童医院“1125人才工程”培养计划项目资助(厦儿〔2019〕39号)
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2024年第59卷第20期
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doi: 10.11669/cpj.2024.20.013
  • 接收时间:2023-03-12
  • 首发时间:2025-12-30
  • 出版时间:2024-10-22
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  • 收稿日期:2023-03-12
基金
厦门市自然科学基金项目资助(3502Z20227144)
厦门市自然科学基金项目资助(3502Z20227145)
厦门市儿童医院“1125人才工程”培养计划项目资助(厦儿〔2019〕39号)
作者信息
    厦门市儿童医院药学部, 福建 厦门 361006

通讯作者:

* 王幼鸿,女,博士,主管药师 研究方向:临床药学 Tel:(0592)2529072
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2种不同金属材料的力学参数

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genus
种数
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species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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